دورية أكاديمية
Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study.
| العنوان: | Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. |
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| المؤلفون: | Topp MS, Gökbuget N, Stein AS, Zugmaier G, O'Brien S, Bargou RC, Dombret H, Fielding AK, Heffner L, Larson RA, Neumann S, FOA, Roberto, Litzow M, Ribera JM, Rambaldi A, Schiller G, Brüggemann M, Horst HA, Holland C, Jia C, Maniar T, Huber B, Nagorsen D, Forman SJ, Kantarjian H.M. |
| المساهمون: | Topp, M, Gökbuget, N, Stein, A, Zugmaier, G, O'Brien, S, Bargou, Rc, Dombret, H, Fielding, Ak, Heffner, L, Larson, Ra, Neumann, S, Foa, Roberto, Litzow, M, Ribera, Jm, Rambaldi, A, Schiller, G, Brüggemann, M, Horst, Ha, Holland, C, Jia, C, Maniar, T, Huber, B, Nagorsen, D, Forman, Sj, Kantarjian, H. M. |
| سنة النشر: | 2015 |
| المجموعة: | Sapienza Università di Roma: CINECA IRIS |
| مصطلحات موضوعية: | bispecific T-cell engager antibody |
| الوصف: | Background Adults with relapsed or refractory B-precursor acute lymphoblastic leukaemia have an unfavourable prognosis. Blinatumomab is a bispecific T-cell engager antibody construct targeting CD19, an antigen consistently expressed on B-lineage acute lymphoblastic leukaemia cells. We aimed to confirm the activity and safety profile of blinatumomab for acute lymphoblastic leukaemia. Methods In a multicentre, single-arm, open-label phase 2 study, we enrolled adult patients with Philadelphia-chromosome- negative, primary refractory or relapsed (first relapse within 12 months of first remission, relapse within 12 months after allogeneic haemopoietic stem-cell transplantation [HSCT], or no response to or relapse after first salvage therapy or beyond) leukaemia. Patients received blinatumomab (9 mu g/day for the first 7 days and 28 mu g/day thereafter) by continuous intravenous infusion over 4 weeks every 6 weeks (up to five cycles), per protocol. The primary endpoint was complete remission (CR) or CR with partial haematological recovery of peripheral blood counts (CRh) within the first two cycles. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT01466179. Findings Between Jan 13, 2012, and Oct 10, 2013, 189 patients were enrolled and treated with blinatumomab. After two cycles, 81 (43%, 95% CI 36-50) patients had achieved a CR or CRh: 63 (33%) patients had a CR and 18 (10%) patients had a CRh. 32 (40%) of patients who achieved CR/CRh underwent subsequent allogeneic HSCT. The most frequent grade 3 or worse adverse events were febrile neutropenia (48 patients, 25%), neutropenia (30 patients, 16%), and anaemia (27 patients, 14%). Three (2%) patients had grade 3 cytokine release syndrome. Neurologic events of worst grade 3 or 4 occurred in 20 (11%) and four (2%) patients, respectively. Three deaths (due to sepsis, Escherichia coli sepsis, and Candida infection) were thought to be treatment-related by the investigators. Interpretation Single-agent blinatumomab showed ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/25524800; info:eu-repo/semantics/altIdentifier/wos/WOS:000346912800045; volume:1; issue:16; firstpage:57; lastpage:66; numberofpages:10; journal:THE LANCET ONCOLOGY; http://hdl.handle.net/11573/780918Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-84926099033 |
| DOI: | 10.1016/S1470-2045(14)71170-2 |
| الإتاحة: | https://doi.org/10.1016/S1470-2045Test(14)71170-2 http://hdl.handle.net/11573/780918Test |
| رقم الانضمام: | edsbas.AA6EDD8A |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S1470-2045(14)71170-2 |
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